Event . | Dual Therapy (n = 126) . | Triple Therapy (n = 123) . | P Value . |
---|---|---|---|
Summary of AEs | |||
Patients with ≥1 AE Total | 88 (70) 197 | 93 (76) 207 | .307 |
Patients with ≥1 grade 2 to 4 AE Total | 15 (12) 17 | 18 (15) 30 | .525 |
Patients with ≥1 serious AE Total | 6 (5) 6 | 6 (5) 7 | .966 |
Discontinuation due to AEs | 1 (1)a | 2 (2)b | .547 |
Deaths | 0 | 0 | NA |
Adverse events that occurred in at least 5% of participants in either group | |||
Respiratory: patients with ≥1 AE Total | 31 (25) 42 | 29 (24) 36 | .850 |
Infections: patients with ≥1 AE Total | 22 (17) 26 | 18 (15) 23 | .544 |
Digestive: patients with ≥1 AE Total | 18 (14) 22 | 22 (18) 27 | .439 |
Muscular or skeletal: patients with ≥1 AE Total | 16 (13) 17 | 22 (18) 27 | .255 |
Neuropsychiatric: patients with ≥1 AE Total | 12 (10) 15 | 12 (10) 15 | .950 |
Metabolic: patients with ≥1 AE Total | 13 (10) 15 | 8 (7) 9 | .279 |
Genitourinary: patients with ≥1 AE Total | 8 (6) 9 | 6 (5) 6 | .614 |
General disorders: patients with ≥1 AE Total | 7 (6) 8 | 7 (6) 8 | .963 |
Ear, nose, throat: patients with ≥1 AE Total | 7 (6) 7 | 8 (7) 8 | .753 |
Oral cavity: patients with ≥1 AE Total | 3 (2) 5 | 7 (6) 7 | .184 |
Event . | Dual Therapy (n = 126) . | Triple Therapy (n = 123) . | P Value . |
---|---|---|---|
Summary of AEs | |||
Patients with ≥1 AE Total | 88 (70) 197 | 93 (76) 207 | .307 |
Patients with ≥1 grade 2 to 4 AE Total | 15 (12) 17 | 18 (15) 30 | .525 |
Patients with ≥1 serious AE Total | 6 (5) 6 | 6 (5) 7 | .966 |
Discontinuation due to AEs | 1 (1)a | 2 (2)b | .547 |
Deaths | 0 | 0 | NA |
Adverse events that occurred in at least 5% of participants in either group | |||
Respiratory: patients with ≥1 AE Total | 31 (25) 42 | 29 (24) 36 | .850 |
Infections: patients with ≥1 AE Total | 22 (17) 26 | 18 (15) 23 | .544 |
Digestive: patients with ≥1 AE Total | 18 (14) 22 | 22 (18) 27 | .439 |
Muscular or skeletal: patients with ≥1 AE Total | 16 (13) 17 | 22 (18) 27 | .255 |
Neuropsychiatric: patients with ≥1 AE Total | 12 (10) 15 | 12 (10) 15 | .950 |
Metabolic: patients with ≥1 AE Total | 13 (10) 15 | 8 (7) 9 | .279 |
Genitourinary: patients with ≥1 AE Total | 8 (6) 9 | 6 (5) 6 | .614 |
General disorders: patients with ≥1 AE Total | 7 (6) 8 | 7 (6) 8 | .963 |
Ear, nose, throat: patients with ≥1 AE Total | 7 (6) 7 | 8 (7) 8 | .753 |
Oral cavity: patients with ≥1 AE Total | 3 (2) 5 | 7 (6) 7 | .184 |
Data are n (%). Dual therapy = switching to darunavir/r + lamivudine. Triple therapy = maintain triple therapy with darunavir/r + 2 nucleos(t)ide reverse transcriptase inhibitors.
Abbreviation: AE, adverse event.
aOne case of hyperlipidemia.
bOne case of diarrhea, one case of Hodgkin’s lymphoma.
Event . | Dual Therapy (n = 126) . | Triple Therapy (n = 123) . | P Value . |
---|---|---|---|
Summary of AEs | |||
Patients with ≥1 AE Total | 88 (70) 197 | 93 (76) 207 | .307 |
Patients with ≥1 grade 2 to 4 AE Total | 15 (12) 17 | 18 (15) 30 | .525 |
Patients with ≥1 serious AE Total | 6 (5) 6 | 6 (5) 7 | .966 |
Discontinuation due to AEs | 1 (1)a | 2 (2)b | .547 |
Deaths | 0 | 0 | NA |
Adverse events that occurred in at least 5% of participants in either group | |||
Respiratory: patients with ≥1 AE Total | 31 (25) 42 | 29 (24) 36 | .850 |
Infections: patients with ≥1 AE Total | 22 (17) 26 | 18 (15) 23 | .544 |
Digestive: patients with ≥1 AE Total | 18 (14) 22 | 22 (18) 27 | .439 |
Muscular or skeletal: patients with ≥1 AE Total | 16 (13) 17 | 22 (18) 27 | .255 |
Neuropsychiatric: patients with ≥1 AE Total | 12 (10) 15 | 12 (10) 15 | .950 |
Metabolic: patients with ≥1 AE Total | 13 (10) 15 | 8 (7) 9 | .279 |
Genitourinary: patients with ≥1 AE Total | 8 (6) 9 | 6 (5) 6 | .614 |
General disorders: patients with ≥1 AE Total | 7 (6) 8 | 7 (6) 8 | .963 |
Ear, nose, throat: patients with ≥1 AE Total | 7 (6) 7 | 8 (7) 8 | .753 |
Oral cavity: patients with ≥1 AE Total | 3 (2) 5 | 7 (6) 7 | .184 |
Event . | Dual Therapy (n = 126) . | Triple Therapy (n = 123) . | P Value . |
---|---|---|---|
Summary of AEs | |||
Patients with ≥1 AE Total | 88 (70) 197 | 93 (76) 207 | .307 |
Patients with ≥1 grade 2 to 4 AE Total | 15 (12) 17 | 18 (15) 30 | .525 |
Patients with ≥1 serious AE Total | 6 (5) 6 | 6 (5) 7 | .966 |
Discontinuation due to AEs | 1 (1)a | 2 (2)b | .547 |
Deaths | 0 | 0 | NA |
Adverse events that occurred in at least 5% of participants in either group | |||
Respiratory: patients with ≥1 AE Total | 31 (25) 42 | 29 (24) 36 | .850 |
Infections: patients with ≥1 AE Total | 22 (17) 26 | 18 (15) 23 | .544 |
Digestive: patients with ≥1 AE Total | 18 (14) 22 | 22 (18) 27 | .439 |
Muscular or skeletal: patients with ≥1 AE Total | 16 (13) 17 | 22 (18) 27 | .255 |
Neuropsychiatric: patients with ≥1 AE Total | 12 (10) 15 | 12 (10) 15 | .950 |
Metabolic: patients with ≥1 AE Total | 13 (10) 15 | 8 (7) 9 | .279 |
Genitourinary: patients with ≥1 AE Total | 8 (6) 9 | 6 (5) 6 | .614 |
General disorders: patients with ≥1 AE Total | 7 (6) 8 | 7 (6) 8 | .963 |
Ear, nose, throat: patients with ≥1 AE Total | 7 (6) 7 | 8 (7) 8 | .753 |
Oral cavity: patients with ≥1 AE Total | 3 (2) 5 | 7 (6) 7 | .184 |
Data are n (%). Dual therapy = switching to darunavir/r + lamivudine. Triple therapy = maintain triple therapy with darunavir/r + 2 nucleos(t)ide reverse transcriptase inhibitors.
Abbreviation: AE, adverse event.
aOne case of hyperlipidemia.
bOne case of diarrhea, one case of Hodgkin’s lymphoma.
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